Regulation of electronic cigarettes
Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely.[1] Others have introduced strict restrictions and some have licensed devices as medicines such as in the UK.[2] As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.[3] Because of the potential relationship with tobacco laws and medical drug policies, e-cigarette legislation is being debated in many countries.[4] The companies that make e-cigarettes have been pushing for laws that support their interests.[5] In 2016 the US Department of Transportation banned the use of e-cigarettes on commercial flights.[6] This regulation applies to all flights to and from the US.[6]
December 5, 2016 HUD passed a new rule[7] banning the use of prohibited tobacco products in common areas and within each home unit. That ban is further extended from the exterior of the building as far as 25 feet from all public housing. It was implemented over the next 18 months. This HUD rule effects more than 700,000 units, including 500,000 for the elderly. The rule was made believing it would lower overall maintenance costs, reduce the risk of catastrophic fires, benefit the overall health of the community and staff as well as help improve indoor air. It will be reevaluated as warranted. HUD did not include electronic cigarettes in their list of prohibited tobacco products, they will allow each public housing agency to make that decision. The ban is on cigarettes, cigars, pipes and waterpipes (hookahs) only. Electronic cigarettes were not included because there was no maintenance cost savings. HUD further stated that the science was still emerging and lacks consensus in contrast to cigarettes and other tobacco products. HUD also responded to comments that there was no conclusive evidence that the vapor causes any damage to the units.[8]
The legal status of e-cigarettes is currently pending in many countries.[9] Many countries such as Brazil, Singapore, the Seychelles, and Uruguay have banned e-cigarettes.[2] In Canada, they are technically illegal to sell, as no nicotine-containing e-cigarette is approved by Health Canada, but this is generally unenforced and they are commonly available for sale Canada-wide.[10] In the US and the UK, the use and sale to adults of e-cigarettes are legal.[11]:US[12]:UK As of August 8, 2016, the US Food and Drug Administration (FDA) extended its regulatory power to include e-cigarettes.[13] Under this ruling the FDA will evaluate certain issues, including ingredients, product features and health risks, as well their appeal to minors and non-users.[14] The FDA rule also bans access to minors.[14] A photo ID is required to buy e-cigarettes,[15] and their sale in all-ages vending machines is not permitted.[14] In May 2016 the FDA used its authority under the Family Smoking Prevention and Tobacco Control Act to deem e-cigarette devices and e-liquids to be tobacco products, which meant it intended to regulate the marketing, labelling, and manufacture of devices and liquids; vape shops that mix e-liquids or make or modify devices were considered manufacturing sites that needed to register with FDA and comply with good manufacturing practice regulation.[16] E-cigarette and tobacco companies have recruited lobbyists in an effort to prevent the FDA from evaluating e-cigarette products or banning existing products already on the market.[17]
In February 2014 the European Parliament passed regulations requiring standardization and quality control for liquids and vaporizers, disclosure of ingredients in liquids, and child-proofing and tamper-proofing for liquid packaging.[18] In April 2014 the FDA published proposed regulations for e-cigarettes.[19][20] In the US some states tax e-cigarettes as tobacco products, and some state and regional governments have broadened their indoor smoking bans to include e-cigarettes.[21] As of 9 October 2015, at least 48 states and 2 territories banned e-cigarette sales to minors.[22]
E-cigarettes have been listed as drug delivery devices in several countries because they contain nicotine, and their advertising has been restricted until safety and efficacy clinical trials are conclusive.[23] Since they do not contain tobacco, television advertising in the US is not restricted.[24] Some countries have regulated e-cigarettes as a medical product even though they have not approved them as a smoking cessation aid.[25] A 2014 review stated the emerging phenomenon of e-cigarettes has raised concerns in the health community, governments, and the general public and recommended that e-cigarettes should be regulated to protect consumers.[26] It added, "heavy regulation by restricting access to e-cigarettes would just encourage continuing use of much unhealthier tobacco smoking."[26] A 2014 review said these products should be considered for regulation in view of the "reported adverse health effects".[25]
Europe
![](../I/m/Legal_status_of_e-cigarettes_in_Europe_2017.svg.png)
On 19 December 2012 the European Commission adopted its proposal to revise the European Union Tobacco Products Directive 2001/37/EC which included proposals to introduce restrictions on the use and sales of e-cigarettes.[27][28][29] On 8 October 2013 the European Parliament in Strasbourg voted down the Commission's proposal to introduce medical regulation for e-cigarettes, but proposed that cross-border marketing of e-cigarettes be regulated similarly to tobacco products, meaning that sales of e-cigarettes to under-18s would be prohibited in the European Union, along with most cross-border advertising. Warning labels also would be required. The Parliament and Member States are involved in trilogue discussions to reach a common conclusion.[30] In February 2014, the European Parliament approved new regulations for tobacco products, including e-cigarettes.[31] The new regulations forbid advertising of e-cigarettes, set limits on maximum concentrations of nicotine in liquids, limit maximum volumes of liquid that can be sold, require child-proof and tamper-proof packaging of liquid, set requirements on purity of ingredients, require that the devices deliver consistent doses of vapor, require disclosure of ingredients and nicotine content, and empower regulators to act if the regulations are violated.[18] In October 2014 e-cigarette manufacturer Totally Wicked won the right to challenge the directive at the Court of Justice of the EU. The hearing took place on 1 October 2015 and the results will not be announced until early 2016.[32]
In autumn 2013, the e-cigarette industry ran "a determined lobbying campaign" to defeat proposed European legislation to regulate e-cigarettes like medical devices.[33] Pharmaceutical manufacturers GlaxoSmithKline and Johnson & Johnson have lobbied the US government, the Food and Drug Administration (FDA), and the EU parliament for stricter regulation of e-cigarettes which compete with their products Nicorette gum and nicotine patches.[34]
![](../I/m/Waken_up_!_No_e-cigarettes_on_public_transport_in_Scotland_(15707341759).jpg)
![](../I/m/No_vaping_sign_Gdansk.jpg)
United States
Federal regulation
Prior to 8 August 2016,[13] regulations concerning the use of e-cigarettes varied considerably across the United States, although there is more variation regarding laws limiting their use by youth than regarding multi-level regulations, such as banning their use in public places.[92] The FDA classified e-cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) before importation and sale in the US.[93] The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, explaining that "the devices should be regulated as tobacco products rather than drug or medical products."[94]
In March 2010, the U.S. Court of Appeals for the District of Columbia stayed the injunction pending an appeal, during which the FDA argued the right to regulate e-cigarettes based on their previous ability to regulate nicotine replacement therapies such as nicotine gum or patches. Further, the agency argued that tobacco legislation enacted the previous year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions."[95] On 7 December 2010, the appeals court ruled against the FDA in a 3–0 unanimous decision, ruling the FDA can only regulate e-cigarettes as tobacco products, and thus cannot block their import.[96] The judges ruled that such devices would only be subject to drug legislation if they are marketed for therapeutic use – E-cigarette manufacturers had successfully proven that their products were targeted at smokers and not at those seeking to quit. The District Columbia Circuit appeals court, on 24 January 2011, declined to review the decision en banc, blocking the products from FDA regulation as medical devices.[97]
In April 2014, the FDA proposed new regulations for tobacco products, including e-cigarettes. The regulations require disclosure of ingredients used in e-cigarette liquids, proof of safety of those ingredients, and regulation of the devices used to vaporize and deliver the liquid.[19][98][99][100] The FDA proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age.[101] In August 2014, attorneys general from over two dozen states advised the FDA to enact restrictions on e-cigarettes, including banning flavors.[102] On 10 May 2016, the FDA published their deeming regulations in the federal register, which takes effect on 8 August 2016. Vendors and companies have until two years afterward to prepare paperwork with the FDA to have their product remain on the market. Currently, there are lawsuits and amendments made in the works in Congress to change that provision. The lack of research on the risks and possible benefits has resulted in precautionary policymaking in the US "which often lacks grounding in empirical evidence and results in spatially uneven diffusion of policy".[11]
As of 8 August 2016, the FDA extended its regulatory power to include e-cigarettes.[13] Under this ruling the FDA will evaluate certain issues, including ingredients, product features and health risks, as well their appeal to minors and non-users.[14] The FDA rule also bans access to minors.[14] A photo ID is required to buy e-cigarettes,[15] and their sale in all-ages vending machines is not permitted.[14] The FDA in September 2016 has sent warning letters for unlawful underage sales to online retailers and retailers of e-cigarettes.[103] FDA regulations have also applied to the advertising of e-cigarettes since 2016.[104] Per FDA regulations, e-cigarettes, e-liquid, and associated products cannot be advertised as safer than other tobacco products unless they have received modified risk tobacco product (MRTP) status.[105] As of August 2018, this status has not been granted to any e-cigarette or e-liquid product.[106] Though no companies have applied for an MRTP permit for their vaping products, similar heat-not-burn tobacco products have been denied MRTP status on the grounds that they are not safer than traditional cigarettes.[107]
Beginning in May 2018, the FDA began to crack down on e-liquid brands whose packaging resembles food or beverage products.[108][109] FDA is particularly concerned about e-liquids whose packaging resembles that of candy, juice boxes, and other products intended to appeal to children, because of concern that children will mistakenly drink the e-liquid and die of nicotine poisoning.[110] Nicotine is especially toxic to young children, and a 60 ml bottle of e-liquid with 11 mg/ml nicotine concentration, the average e-liquid bottle in the U.S.,[111] is likely to kill a child of age 4 or younger.[110][112] As such, the FDA has charged e-liquid products with branding that resembles food, candy, or beverage items as being misbranded and using false advertising, which is illegal under the Tobacco Control Act of 2009 (specifically sections 903(a)(1) and 903(a)(7)(A) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 387c).[110]
State regulation
![A no smoking or vaping sign from the US.](../I/m/No_Vaping_Sign_(18562436519).jpg)
Effective 8 August 2016, all US states will follow the same, uniform federal guidelines.[13] With an absence of federal regulations, many states and cities had adopted their own e-cigarette regulations, most commonly to prohibit sales to minors, including Maryland, Kentucky, Minnesota, New Jersey, New Hampshire, Tennessee, Utah, Wisconsin, and Colorado. Other states are considering similar legislation.[113] Several US cities and states have enacted laws that increased the legal age to purchase e-cigarettes to age 21.[114] As of 2014, some states in the US permit e-cigarettes to be taxed as tobacco products, and some state and regional governments in the US had extended their indoor smoking bans to include e-cigarettes.[21]
Governor Arnold Schwarzenegger vetoed a bill that would regulate the sale of e-cigarettes within the state on grounds that "if adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so."[115]
A review of regulations in 40 U.S. states found that how a law defines e-cigarettes is critical, with some definitions allowing e-cigarettes to avoid smoke-free laws, taxation, and restrictions on sales and marketing.[116] Less policies have been created to restrict vaping indoors than with cigarette smoking.[117]
Many local and state jurisdictions have recently begun enacting laws that prohibit e-cigarette usage everywhere that smoking is banned, although some state laws with comprehensive smoke-free laws will still allow for vaping to be permitted in bars and restaurants while prohibiting e-cigarettes in other indoor places.[118] As of August 2016, the United States Navy is considering banning e-cigarettes.[119] A 2017 report stated "As of 2 October 2015, five US states and over 400 counties have implemented some form of restriction of ECIG use indoors. International policies are more varied with certain restrictions for ECIG use in UK airports and trains and reports of complete ECIG bans in indoor public places for Malta, Belgium and Spain".[117]
Other countries
![](../I/m/No_vaping_sign_(Canada%2C_2015%2C_cropped).jpg)
The states of Karnataka, Kerala, Punjab, Jammu and Kashmir, Mizoram and Maharashtra have banned e-cigarettes under the Drugs and Cosmetics Act, 1940, and Food Safety & Standards (Prohibition and Restriction on Sales) Regulation, 2011.[143] In August 2018, the Central Government had asked the states to ban all types of Electronic Nicotine Delivery Systems.[144][145]
References
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- ↑ Gray, Eliza (27 February 2014). "Europe Sets New Rules for E-Cigs While the U.S. Drags Its Feet". Time.
- ↑ James Meikle (1 October 2015). "UK e-cigarette firm fights EU vaping laws in European court". The Guardian. Retrieved 21 October 2015.
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- ↑ Makiko Kitamura (19 February 2014). "Glaxo Memo Shows Drug Industry Lobbying on E-Cigarettes". Bloomberg News. Retrieved 22 November 2014.
- ↑ "Ինչ եղավ, երբ էլեկտրոնային սիգարետները փորձարկեցին մկների վրա" (text) (in Armenian). 168hours. 1 March 2015. Retrieved 20 June 2016.
- ↑ "Abgrenzungsbeirat gemäß § 49a AMG BMGFJ-Information betreffend elektrisch betriebene Nikotininhalatoren, insbesondere RUYAN" (PDF). Austrian Agency for Health and Food Safety. 18 April 2007. Archived from the original (PDF 29 KB) on 27 September 2007. Retrieved 21 September 2011.
- ↑ "La cigarette électronique bientôt complètement légale en Belgique" (text) (in French). LE SOIR. 26 January 2016. Retrieved 20 June 2016.
- ↑ "LAW ON THE BAN ON THE SALE AND CONSUMPTION OF TOBACCO PRODUCTS TO PERSONS BELOW 18 YEARS OF AGE" (text). tobaccocontrollaws.org. 21 May 2004. Retrieved 20 June 2016.
- ↑ Gregor Erbach (27 March 2013). "Electronic cigarettes" (PDF). Retrieved 6 October 2013.
- ↑ "Zabranjeno pušenje: i elektronska cigareta uskoro na udaru zakona!" (text) (in Croatian). vijesti.rtl.hr. 21 May 2004. Retrieved 1 September 2015.
- 1 2 "Zákon o opatreních k ochrane pred škodami pusobenými tabákovými výrobky, alkoholem a jinými návykovými látkami". Czech Law. Retrieved 20 February 2015.
- 1 2 3 4 5 Tiessen; et al. (2010). "Assessing the Impacts of Revising the Tobacco Products Directive" (PDF). RAND Europe commission by the European Commission Health and Consumer Director. pp. 118–120.
- ↑ Danish Medicines Agency (9 March 2009). "Classification of electronic cigarettes". Danish Medicines Agency. Retrieved 22 February 2010.
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- ↑ "Summary of legal rulings and case precedents" (PDF). Electronic Cigarette Industry Trade Association. January 2013. Retrieved 30 December 2014.
- ↑ "Tupakan esilläpitokielto voimaan – Sähkötupakan mainonta lainvastaista". Valvira.fi. Retrieved 29 February 2012.
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- ↑ Press release Finnish Customs, 26 November 2010. Retrieved 6 March 2011.
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- ↑
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- 1 2 "Protection of Young Persons Act § 10" (PDF). www.bmfsfj.de. Bundesministerium für Familie, Senioren, Frauen und Jugend. 3 March 2016. Retrieved 28 May 2016.
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- 1 2 "E-Cigarette Committee- Where is it legal?". eexplor. Retrieved 18 November 2013.
- ↑ "Kinder- und Jugendgesetz (KJG) Art. 69 Alkoholhaltige Getränke und Tabakwaren". www.gesetze.li (in German). 2008-12-10. Retrieved 11 June 2016.
- ↑ "Accueil – JWELL STORE LUXEMBOURG". www.jwell-luxembourg.lu (in French). Retrieved 2018-07-14.
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- ↑ Tobacco (Smoking Control) Act Sec. 13
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- ↑ "Regulering av elektroniske sigaretter i Norge" (PDF). Helsedirektoratet Norge. 6 December 2011.
Etter legemiddellovgivningen er overnevnte regler ikke til hinder for privatimport fra utlandet. Dersom produktet privatimporteres til røykeslutt, gjelder reglene i forskrift om tilvirkning og import av legemidler § 3-2. Her stilles det ulike krav avhengig av hvilket land (innenfor eller utenfor EØS) det importeres fra og hvordan (ved innreise eller forsendelse). Produktet må være lovlig ervervet og til personlig bruk
- ↑ "Norway bans e-cigarette advertising". Odisha Sun Times. July 26, 2015. Retrieved 3 August 2018.
- ↑ "Dz.U. 2016 poz. 1331". Sejm - Internetowy System Aktów Prawnych.
- ↑ Walków, Marcin. "Palisz e-papierosy? Od dziś grozi za to mandat". Business Insider Polska. Retrieved 8 September 2017.
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- ↑ Jimenez Ruiz, CA; Solano Reina, S; de Granda Orive, JI; Signes-Costa Minaya, J; de Higes Martinez, E; Riesco Miranda, JA; Altet Gómez, N; Lorza Blasco, JJ; Barrueco Ferrero, M; de Lucas Ramos, P (August 2014). "The electronic cigarette. Official statement of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) on the efficacy, safety and regulation of electronic cigarettes". Archivos de Bronconeumologia. 50 (8): 362–7. doi:10.1016/j.arbres.2014.02.006. PMID 24684764.
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For safety reasons, on our buses and Underground trains and in our bus and Underground stations you must not smoke or use an electronic cigarette (‘vape’)
- ↑ "So where can you still vape? - BBC Newsbeat". BBC Newsbeat. 6 October 2015. Retrieved 27 September 2018.
- ↑ "Rules about tobacco, e-cigarettes and smoking: 1 October 2015". GOV.UK. Department of Health. 9 July 2015.
- ↑ "E-cigarettes can appear in TV adverts, watchdog rules". BBC News. 9 October 2014.
- ↑ Alex Bell (10 November 2014). "E-cigarette firm KiK to make TV history". Manchester Evening News.
- ↑ Morris, Steven (9 June 2015). "Wales to introduce e-cigarette ban". The Guardian. Retrieved 26 October 2015.
- ↑ "What the RCP thinks about tobacco". UK: Royal College of Physicians. 2018-02-01. Retrieved 2018-05-03.
- ↑ "E-cigarettes: regulations for consumer products". gov.uk. Retrieved May 6, 2018.
- ↑ Tremblay, MC; Pluye, P; Gore, G; Granikov, V; Filion, KB; Eisenberg, MJ (3 June 2015). "Regulation profiles of e-cigarettes in the United States: a critical review with qualitative synthesis". BMC Medicine. 13: 130. doi:10.1186/s12916-015-0370-z. PMC 4480885. PMID 26041672.
- ↑ "FDA Fighting for Authority to Regulate Electronic Cigarette". 2 March 2010.
- ↑ Wilson, Duff (15 January 2010). "Judge Orders F.D.A. to Stop Blocking Imports of E-Cigarettes From China". The New York Times.
- ↑ "AAFP.org". AAFP.org. Retrieved 18 December 2010.
- ↑ "FDA Cannot Block E-Cigarette Imports: Court". Fox News. 8 December 2010.
- ↑ FDA (14 February 2011). "FDA regulation of e-cigarettes rebuffed again". American Medical News. Retrieved 21 February 2011.
- ↑ Richtel, Matt (3 May 2014). "Some E-Cigarettes Deliver a Puff of Carcinogens". The New York Times. Retrieved 4 May 2014.
- ↑ Brady Dennis for the Washington Post. 24 April 2014 FDA outlines plan to regulate e-cigarettes
- ↑ Sabrina Tavernise for the New York Times. 24 April 2014 F.D.A. Will Propose New Regulations for E-Cigarettes
- ↑ Rom, Oren; Pecorelli, Alessandra; Valacchi, Giuseppe; Reznick, Abraham Z. (2014). "Are E-cigarettes a safe and good alternative to cigarette smoking?". Annals of the New York Academy of Sciences. 1340: 65–74. doi:10.1111/nyas.12609. ISSN 0077-8923. PMID 25557889.
- ↑ Marilynn Marchione (25 August 2014). "Heart group says e-cigarettes may help end habit". The Boston Globe. Associated Press.
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